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Status unknownNCT03435094Updated Dec 3, 2020

Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes

An observational study in Osteoporosis, Postmenopausal, sponsored by Labatec Pharma SA. Status unknown at 2 sites in Switzerland. Open to female participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-12-03.

Sponsored by Labatec Pharma SA · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
55 Years to 90 Years
Sex
Female
01

Study summary

Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).

02

Conditions studied

  • Osteoporosis, Postmenopausal
03

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Post-menopausal women with osteoporosis, on treatment with Fosamax® or Binosto® for 6-8 months and who will be continued to be treated for a minimum of 12 months, with available BTMs, biochemistry and DXA at the initiation are to be offered participation in the study at the discretion of the treating physician.

Inclusion criteria

  • Post-menopausal women (at least 5 years after natural / surgical menopause).
  • Patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months.
  • Available BTMs (s-CTX), biochemistry (calcium, phosphate, 25-OH vit D, PTH, creatinine) and DXA (lumbar spine, total hip and femoral neck) at the initiation of the treatment.
  • Ability to sign an informed patient consent

Exclusion criteria

Exclusion Criteria:

  • Patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg.
  • Any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption
  • Metabolic or cancer bone disease
  • Contra-indications to bisphosphonates according to product labelling
  • Known or suspected allergy to study product(s) or related products
  • Inability to sign an informed consent
  • Previous participation in this study
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fosamax®

    1 group will be treated with alendronate 70 mg tablets (Fosamax®)

    Drug: Fosamax 70Mg Tablet

  • Binosto®

    1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®)

    Drug: Binosto 70Mg Effervescent Tablet

Interventions

  • DrugBinosto 70Mg Effervescent Tablet

    Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.

  • DrugFosamax 70Mg Tablet

    Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.

05

What researchers measure

Primary outcomes

  1. s-CTX

    Decrease in the rate of the bone resorption marker s-CTX

    Time frame: Change at 6 months, 12 months, 18 months after treatment start

06

Study locations

2 of 2 sites recruiting
  • Endokrinologische Praxis & Labor
    Basel, BS 4055, Switzerland
    • Christian Meier, Prof · Contact
    Recruiting
  • Hôpital Universitaire de Genève, Service des maladies osseuses
    Genève, GE 1211, Switzerland
    • Serge Ferrari, Prof · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03435094
Lead sponsor
Labatec Pharma SA
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Feb 25, 2018
Primary completion
Mar 31, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Dec 3, 2020

Study contacts

Aurélie TIREFORD, PharmD
Contact
aurelie.tireford@labatec.com
+41 22 593 78 54
Aurélie TIREFORD, PharmD
study director · Labatec Pharma SA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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